Nuwellis Announces Issuance of New U.S. Patent Supporting Advanced Safety Design for Pediatric Extracorporeal Therapy

Nuwellis (Nasdaq: NUWE) announced that the U.S. Patent and Trademark Office issued a new U.S. patent tied to U.S. Patent Application No. 18/298,810 on January 6, 2026.

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) announced that the U.S. Patent and Trademark Office issued a new U.S. patent tied to U.S. Patent Application No. 18/298,810 on January 6, 2026.

The patent covers advanced safety mechanisms for blood return line clamps in extracorporeal blood filtration systems, with specific relevance to pediatric extracorporeal therapy and the Vivian™ Pediatric CRRT System currently in development. Nuwellis said the invention aims to improve reliability and consistency of blood flow control, support stable system performance for small patient volumes, and strengthen the company’s pediatric intellectual property portfolio and cardio-renal strategy.

Argus Jan 6 session

+4.62% close to close Open Argus

Details

News Market Reaction – NUWE

On Jan 6, the day this news came out, NUWE closed 4.62% above the previous close.

Data tracked by StockTitan Argus for the Jan 6 session.

Key Figures

Patent application number: 18/298,810

Patent application number

18/298,810

U.S. Patent Application referenced in newly issued patent

Historical Context

5 past events · Latest: Dec 09

5 events

1. Dec 09

   Clinical data update

   24h Move

   -1.3%

   Real-world Aquadex data from 69 critical-care cases presented at ASN Kidney Week.

2. Dec 04

   Commercial adoption

   24h Move

   +9.8%

   Leading Northeast children’s hospital initiated an Aquadex ultrafiltration program.

3. Nov 12

   Quarterly earnings

   24h Move

   -4.0%

   Q3 2025 revenue down year-over-year with operating loss despite sequential growth.

4. Nov 10

   Patent allowance

   24h Move

   -5.6%

   Notice of allowance for advanced clamp safety patent for Vivian Pediatric CRRT System.

5. Oct 23

   Earnings scheduling

   24h Move

   -3.5%

   Announcement of timing and access details for Q3 2025 earnings call and webcast.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

extracorporeal blood filtration systems, extracorporeal circuits, pediatric continuous renal replacement therapy (crrt), intellectual property, +2 more

6 terms

extracorporeal blood filtration systems medical

"safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems"

Extracorporeal blood filtration systems are medical devices that clean or remove specific substances from a patient’s blood outside the body, using a machine and disposable filter—think of a water purifier that runs blood through a cartridge to take out toxins, excess fluid, or disease-causing particles. Investors care because these systems address critical and often recurring medical needs, creating ongoing revenue from devices and consumables while depending on hospital adoption, regulatory clearance and reimbursement policies that drive commercial value and risk.

extracorporeal circuits medical

"blood flow control in extracorporeal circuits, with particular relevance for pediatric"

Extracorporeal circuits are medical systems of tubing, pumps and filters that temporarily move a patient’s blood or other bodily fluids outside the body to perform support functions such as oxygenation, filtration or temperature control. Think of them as a temporary external plumbing loop and machine that does part of an organ’s work. Investors watch them because sales, disposables, approvals and safety outcomes directly affect device makers’ revenue, costs and regulatory risk.

pediatric continuous renal replacement therapy (crrt) medical

"supporting the Vivian™ Pediatric Continuous Renal Replacement Therapy (CRRT) System"

Pediatric continuous renal replacement therapy (CRRT) is a form of dialysis used for critically ill infants and children that runs continuously to remove waste, excess fluid, and balance electrolytes when a child’s kidneys are failing. Think of it as a gentle, nonstop filtration system that keeps the body's chemistry stable when the natural filter is overwhelmed. Investors watch adoption, device and supply sales, staffing needs, and reimbursement for CRRT because they affect hospital costs, procedure volumes, and revenues for medical equipment and service providers.

intellectual property technical

"formal issuance of intellectual property supporting the Vivian™ Pediatric"

Intellectual property are legal rights that protect creations of the mind—such as inventions, brand names, designs, software, or secret formulas—giving the owner control over who can use, copy or sell them. For investors, IP is like owning a blueprint or recipe: it can generate steady income through exclusive sales or licensing, boost a company’s competitive edge and valuation, and also create costs or risks if rights must be defended or challenged in court.

cardio-renal continuum medical

"advancing precision fluid management technologies across the cardio-renal continuum"

A cardio-renal continuum describes the close, two-way connection between heart and kidney health where problems in one organ often lead to worsening in the other, like two neighboring rooms sharing a leaking pipe. For investors, it matters because therapies, diagnostics, or devices that help one organ can affect outcomes and costs across both, expanding market size, influencing regulatory paths, and shaping long-term healthcare spending and patient demand.

u.s. patent and trademark office regulatory

"the United States Patent and Trademark Office recently issued a new U.S. patent"

The U.S. Patent and Trademark Office is the federal agency that reviews and grants patents and registers trademarks, like a land office that issues official property deeds for inventions and brand names. For investors, its decisions matter because patents and trademarks can create legal protection and exclusive market rights that boost a company’s revenue potential, reduce competition, and change risk and valuation dynamics.

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Patent issuance strengthens pediatric intellectual property portfolio and advances system-level safety design

MINNEAPOLIS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company advancing precision fluid management technologies across the cardio-renal continuum today announced that the United States Patent and Trademark Office recently issued a new U.S. patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems. The issued patent corresponds to U.S. Patent Application No. 18/298,810 and is assigned to Nuwellis.

The newly issued patent protects safety-focused design innovations intended to improve the reliability and consistency of blood flow control in extracorporeal circuits, with particular relevance for pediatric applications, where precision and safety are critical. These mechanisms are designed to support stable system performance and enhance protection in therapies involving small patient volumes and sensitive extracorporeal conditions.

This patent issuance follows the previously announced Notice of Allowance and represents the formal issuance of intellectual property supporting the Vivian™ Pediatric Continuous Renal Replacement Therapy (CRRT) System, which is currently in development. The issuance further strengthens Nuwellis’ growing portfolio of issued and pending patents supporting pediatric system design and circuit-level safety.

“Each issued patent reflects continued progress in building a strong foundation of protected innovation,” said John Erb, Chief Executive Officer of Nuwellis. “This milestone reinforces our commitment to engineering precision and safety into technologies intended for the most vulnerable patient populations.”

The patent adds to Nuwellis’ expanding intellectual property portfolio, supporting its pediatric development roadmap and broader cardio-renal strategy and underscoring the Company’s focus on advancing precision fluid management technologies that support safe, reliable care across diverse patient populations and clinical settings.

For more information, visit www.nuwellis.com.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company advancing precision technologies across the cardio-renal continuum. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardio-renal conditions, with a focus on safety, precision, and scalability across patient populations.

Nuwellis is headquartered in Minneapolis, Minnesota, with a wholly owned subsidiary in Ireland. For more information, visit www.nuwellis.com or follow the Company on LinkedIn and X.

About the Aquadex SmartFlow^® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

About Vivian Vivian is a purpose-built pediatric CRRT system designed for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO₂ sensors for real-time monitoring. Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.

Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.

Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

For further information, please contact:

Investor Relations:
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Nuwellis (NUWE) announce on January 6, 2026 regarding a U.S. patent?

Nuwellis announced issuance of a U.S. patent for safety mechanisms for blood return line clamps tied to U.S. Patent Application No. 18/298,810.

How does the new NUWE patent relate to the Vivian Pediatric CRRT System?

The patent is described as supporting the Vivian Pediatric CRRT System under development by protecting circuit-level safety design innovations for pediatric use.

Why is the issued patent important for pediatric extracorporeal therapy and investors in NUWE?

The company says the patent strengthens its pediatric IP portfolio and supports precision safety features intended to improve reliability in small-volume pediatric extracorporeal circuits.

Does the new NUWE patent include a U.S. application number and assignment details?

Yes; it corresponds to U.S. Patent Application No. 18/298,810 and is assigned to Nuwellis.

Where can investors find more information about Nuwellis patent announcements and product development?

Investors can visit the company website at www.nuwellis.com for additional details and updates.